Study Completed

Prostate Cancer, Ovarian Cancer

Bayer Identifier:

91695

ClinicalTrials.gov Identifier:

NCT00751205

EudraCT Number:

2008-000879-26

EU CT Number:

Not Available

Prevention of Sagopilone-induced neurotoxicity with Acetyl-L-Carnitine (ALC)

Trial purpose

This study investigates the safety and efficacy of Acetyl-L-Carnitine and compares it to the safety and efficacy of a placebo (inactive) tablet in the prevention of Sagopilone-induced peripheral neuropathy. Patients will receive intravenous infusion of sagopilone for 3 hours on day 1 of a 3-weeks cycle. Treatment with Sagopilone will be given as long as the patient is benefitting. In addition patients will receive ALC or placebo, starting 1 week before first sagopilone infusion and ending 30-33 days after the last infusion with sagopilone. Safety will be determined by laboratory and other evaluations. Efficacy of ALC will be determined by the incidence of all grades of peripheral neuropathy with the results of a patient questionnaire. Efficacy of the combination of ALC and Sagopilone will be determined by the tumor response.

Key Participants Requirements

Sex

Both

Age

18 - 70 Years

Inclusion Criteria
- Males or females aged >/= 18 years
- Epithelial ovarian, peritoneal cavity or Fallopian
tube cancer (except mucinous or clear cell
tumors) or Adenocarcinoma of the prostate
- At least 1 unidimensional measurable lesion
(suitable for RECIST evaluation) or for patients
without measurable disease, CA 125 levels >/= 2 times the upper limit of normal (ULN) within 3
months and confirmed within 2 weeks prior to
first infusion (ovarian cancer) or PSA value >/= 5 ng/mL (HRPC).
- Progression of disease (HRPC) despite adequate androgen-inhibiting hormone therapy.
- Progression of disease (Ovarian Cancer) or
symptomatic relapse after previous therapy
(elevated CA125 levels alone are insufficient for inclusion) WHO performance status 0 to 1
- No clinical residual neuropathy (CTCAE Grade
0 at baseline)
- Adequate recovery from previous surgery,
radiation, and chemotherapy (excluding alopecia)
- Adequate function of major organs and systems.
- Survival expectation =3 months
- Histologically or cytologically proven:
a) Epithelial ovarian, peritoneal cavity or Fallopian tube cancer (except mucionous cell tumors or clear cell tumors that have a clear cell component of >33%)
Exclusion Criteria
- Symptomatic brain metastases requiring whole-
brain irradiation
- Any concomitant malignancy: the following exceptions are allowed: Non-melanoma skin
cancer, Carcinoma in situ of the cervix, Malignancy with definitive treatment >/= 5 years ago without relapse.
- Diabetes mellitus (even if controlled only by
special diet)
- History of chronic hepatitis B or C, or known
HIV infection
- Seizure disorder requiring medication (such as
steroids or anti-epileptics)
- Inability to swallow oral medications
- Prior treatment with epothilones
- Concomitant use of neurotoxic drugs
- Concomitant use of compounds that have
potentially positive effects towards symptoms
of neuropathy

Trial summary

Enrollment Goal

150

Trial Dates

August 2008 - August 2010

Phase

Phase 2

Could I Receive a placebo

Products

Sagopilone (BAY86-5302)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Klinikum der Eberhard-Karls-Universität Tübingen	Tübingen, 72076, Germany
Completed	Universitätsklinikum Essen	Essen, 45122, Germany
Completed	Klinikum Südstadt	Rostock, 18059, Germany
Completed	Centre René Gauducheau	Nantes, 44805, France
Completed	Centre René Gauducheau - Nantes	NANTES, 44805, France
Completed	Diaconesses Croix Saint Simon - Paris	Paris, 75012, France
Completed	Centre Val d'Aurelle - Montpellier	MONTPELLIER CEDEX, 34298, France
Completed	IRST Istituto Scientifico Romagnolo per studio e cura Tumori	Meldola, 47014, Italy
Completed	AUSL Rimini - Emilia Romagna	Rimini, 47900, Italy
Completed	Academisch Ziekenhuis Maastricht	Maastricht, 6229 HX, Netherlands
Completed	Vrije Universiteit Medisch Centrum	AMSTERDAM, 1081 HV, Netherlands
Completed	Universitätsklinikum Essen	Essen, 45147, Germany
Completed	Otto-von-Guericke-Universität Magdeburg	Magdeburg, 38108, Germany
Completed	Medizinische Einrichtungen der Universität Bonn	Bonn, 53105, Germany
Completed	Mount Vernon Hospital	Northwood, HA6 2RN, United Kingdom
Completed	Leicester Royal Infirmary	Leicester, LE1 5WW, United Kingdom
Completed	Centre Francois Baclesse	Caen, 14076, France
Completed	Institut Gustave Roussy - Villejuif	VILLEJUIF, 94805, France
Completed	A.O.U. di Bologna	Bologna, 40138, Italy
Completed	A.O. Sant'Andrea	Roma, 00189, Italy
Completed	CU Saint-Luc/UZ St-Luc	BRUXELLES - BRUSSEL, 1200, Belgium
Completed	Nederlands Kanker Instituut	Amsterdam, 1066 CX, Netherlands
Completed	Leids Universitair Medisch Centrum	Leiden, 2333 ZA, Netherlands

Primary Outcome

Overall incidence of peripheral neuropathy (any grade) during at most 6 cycles of Sagopilone treatment, based on the Adverse Events.
Time Frame:
Start of Sagopilone treatment until at most 6 cycles + 1 month.
Safety Issue:
yes

Secondary Outcome

Efficacy of ALC: incidence of neuropathy of grade 3 or 4, time to onset of neuropathy, duration of neuropathy.
Time Frame:
Start of treatment to safety Follow-up
Safety Issue:
yes
Efficacy of ALC: Percentage of discontinuations due to neuropathy.
Time Frame:
Start of treatment to safety Follow-up
Safety Issue:
no
Safety of Sagopilone in combination with ALC.
Time Frame:
Baseline to Safety follow-up
Safety Issue:
yes
Efficacy of Sagopilone: 'best overall response' according to modRECIST criteria
Time Frame:
Start treatment to End of Treatment
Safety Issue:
no
Efficacy of Sagopilone: 'best overall response' according to CA-125 or PSA response
Time Frame:
Start treatment to End of Treatment
Safety Issue:
no
Efficacy of Sagopilone: Time to disease progression, Progression-free survival
Time Frame:
Start treatment to Progression or Death
Safety Issue:
no
Efficacy of Sagopilone: Duration of response
Time Frame:
Start treatment to Progression or Death
Safety Issue:
no
Efficacy of Sagopilone: WHO performance status.
Time Frame:
Screening to end of Treatment
Safety Issue:
no
Pharmacokinetic: Sagopilone concentrations (optional)
Time Frame:
Day 1,2,3,5,15 of cycle 1 and day2
Safety Issue:
no
Pharmacokinetic: ALC concentrations
Time Frame:
radomisation, day 1 of cycle 1 and 2
Safety Issue:
no
Pharmacogenomics (optional): in tumor tissue, blood and ascites
Time Frame:
Blood sample at screening, tissue sample and ascites whenever available
Safety Issue:
no

Trial design

(REASON) Double-blind, Randomized phase II study to Evaluate the safety and efficacy of Acetyl-l-carnitine in the prevention of Sagopilone-induced peripheral Neuropathy.

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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